Update on Drugs & Drug News

The US FDA approved this monoclonal antibody in May 2005 for the treatment of psoriatic arthritis. This is the ninth new indication for this product.

Health Advisory

CyproteroneEthinylDiane-35Berlex

TPP Canada issued a Health Advisory in May 2005 informing consumers of a new version of the product monograph agreed upon by Berlex and TPP Canada that includes the following information:

This product must not be used in women withthrombohebitis, thromboembolic disorders, or a history of these conditions.

Some published studies show that Diane-35® users appear to have an elevated risk of blood clots compared with users of combination oral contraceptives.

Diane-35® should not be prescribed for birth control alone.

Oral contraceptives should not be taken during treatment with Diane-35®.

Diane-35® should be discontinued 3-4 months after signs of acne have completely resolved.

Consumers should be aware that cigarette smoking increases the risk of serious adverse effects on the heart and blood vessels from Diane-35® use.

Any occurrences of thromboembolic disorders (blood clots) or other serious and/or unexpected adverse reactions in patients taking Diane-35® should be reported to TPP Canada.

Drug News

Antipsoriatic Agent

Biogen Idec and Fumapharm AG in April 2005, announced results from a multicenter, double-blind, placebo-controlled Phase III study designed to evaluate the efficacy and safety of BG-12, an oral fumerate, in the treatment of moderate-to-severe psoriasis. The trial met the primary endpoint andpatients receiving BG-12 demonstrated a statistically significant clinical improvement as measured by a lower median psoirasis severity score after 16 weeks of treatment compared with patients receiving placebo. The median PASI was 5.8 for the BG-12 group and 14.2 for the placebo group.Median percentage reduction from baseline PASI was 68% for patients receiving BG-12 and 10% for patients receiving placebo.

Hair Dye

In an article recently published in of the scientific evidence lookingstrong evidence of increased risk. hematopoietic cancers (e.g., leukemia of a causal effect is too weak to represent a major public health concern.